MEVATRON 67E— 510(k) K812032
Substantially EquivalentSiemens Medical Laboratories, Inc.
FDA 510(k) clearance K812032 for MEVATRON 67E, Substantially Equivalent on 1981-08-18. Applicant: Siemens Medical Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Laboratories, Inc.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code IYE
view allMore clearances from Siemens Medical Laboratories, Inc.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K812032
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K812032.
Data sourced from openFDA. This site is unofficial and independent of the FDA.